UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020829 |
|---|---|
| Receipt number | R000022370 |
| Scientific Title | Desensitization therapy for preexisted anti-HLA antibody with anti-CD20 Antibody, plasma exchange, and immunoglobulin in kidney transplantation |
| Date of disclosure of the study information | 2016/02/01 |
| Last modified on | 2019/08/05 19:01:59 |
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Basic information
Public title
Desensitization therapy for preexisted anti-HLA antibody with anti-CD20 Antibody, plasma exchange, and immunoglobulin in kidney transplantation
Acronym
desensitization therapy for preexisted anti-HLA antibody
Scientific Title
Desensitization therapy for preexisted anti-HLA antibody with anti-CD20 Antibody, plasma exchange, and immunoglobulin in kidney transplantation
Scientific Title:Acronym
desensitization therapy for preexisted anti-HLA antibody
Region
| Japan |
Condition
Condition
kidney transplantation recipients with preexisted anti-HLA antibody
Classification by specialty
| Nephrology | Urology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm a safety of desensitization therapy, including rituximab administration, for kidney transplantation recipients with HLA-Donor specific antibody positive.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
graft failure rate
Key secondary outcomes
patient survival rate
rate of allograft rejection
adverse effect rate
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Rituximab administration
single dose administration of 200mg/body before renal transplantation
Plasma exchange
three to four times replaced by albumin
Immunoglobulin administration
IVIG 2-3g/kg when donor specific antibody is high MFI (>3000)
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Kidney transplantation recipients with HLA-donor specific antibody at Division of Nephrology and hypertension, department of internal medicine, and Urology, The Jikei University of Medicine.
2)The patient who can have a decision about the participation of this study voluntary, and understand consent brief and other explanation documents.
Key exclusion criteria
1) The patients with serious hypersensitivity or medical history of anaphylaxis for the products derived from mouse protein, Rituximab, immunoglobulin, and an integrent of the albumin to prepare plasma exchange.
2) The patients whom the medical attendant judged when the exacerbation of the sign exceeded benefit of Rituximab among them who have severe infectious diseases, a cardiac dysfunction, respiratory diseases, or a bone marrow dysfunction.
3) The patients with an medical history of the drug hypersensitivity and the allergic to albumin (preparation for plasma exchange), Rituximab or immunoglobulin whom the medical attendant judged when these adverse effects exceeded the benefits of these medications.
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Yokoo |
Organization
The Jikei University of Medicine
Division name
Division of Nephrology and Hypertension, Department of Internal Medicine
Zip code
105-8461
Address
Minato-ku, Tokyo
TEL
+81-3-3433-1111
nakadaya@jikei.ac.jp
Public contact
Name of contact person
| 1st name | Yasuyuki |
| Middle name | |
| Last name | Nakada |
Organization
The Jikei University of Medicine
Division name
Division of Nephrology and Hypertension, Department of Internal Medicine
Zip code
105-8461
Address
3-25-8, Nishi-Shinbashi, Minato-ku, Tokyo
TEL
+81-3-3433-1111
Homepage URL
tyokoo@jikei.ac.jp
Sponsor or person
Institute
Division of Nephrology and Hypertension, Department of Internal Medicine, The Jikei University of Medicine
Institute
Department
Personal name
Funding Source
Organization
Division of Nephrology and Hypertension, Department of Internal Medicine, The Jikei University of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Division of Hypertension and Nephrology, Department of Internal Medicine, The Jikei University School of Medicine
Address
3-25-8, Nishi-shimbashi, Minato-ku, Tokyo
Tel
+81334331111
nakadaya@jikei.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 02 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2016 | Year | 01 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 01 | Month | 27 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 02 | Month | 01 | Day |
Last modified on
| 2019 | Year | 08 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022370
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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